Acidic insulin preparations having improved stability
AssigneeSanofi-Aventis Deutschland GmbH
InventorsAnette Brunner-Schwarz, Norbert Lill
Life of this patent
Estimating the term…
Abstract
The invention relates to a pharmaceutical formulation comprising a polypeptide selected from the group consisting of insulin, an insulin metabolite, an insulin analog, an insulin derivative and combinations thereof; a surfactant or combinations of two or more surfactants; optionally a preservative or combinations of two or more preservatives; and optionally an isotonicizing agent, buffers or further excipients or combinations thereof, the pharmaceutical formulation having a pH in the acidic range.
Claims25
A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin;
- at least one chemical entity chosen from polysorbate 20 and polysorbate 80;
- at least one preservative;
- and
- water,
- wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.
A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin,
- at least one chemical entity chosen from polysorbate and poloxamers;
- at least one preservative;
- and
- water,
- wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.
A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin:
- at least one chemical entity chosen from polysorbate and poloxamers;
- at least one preservative chosen from cresol;
- and
- water,
- wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 4.5.
Dependencies are inferred from the claim text.